Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-25 @ 2:29 AM
Ignite Modification Date: 2025-12-26 @ 1:04 AM
NCT ID: NCT03117634
Description: Adverse events : Any Hospitalisation for routine treatment or monitoring of the studied indication not associated with any deterioration in condition, hospitalisation for elective or preplanned treatment for a pre-existing condition that is unrelated to the indication under study and has not worsened since the start of the study and treatment on an emergency outpatient basis for an event not fulfilling the definitions of a SAE given above and not resulting in hospital admission.
Frequency Threshold: 0
Time Frame: The Adverse events (AE) and serious Adverse events (SAE) were recorded on or after the date of the administration of first study treatment, for an average of 1 year.
Study: NCT03117634
Study Brief: An Open Label-study to Compare the Efficacy of Aflibercept Monotherapy for Polypoidal Choroidal Vasculopathy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Personalised Group The participants received an induction phase of treatment defined as 4 weekly intravitreal aflibercept 2mg/0.05ml at week 0, week 4 and week 8. At week 12, the participants had repeat ICGA and OCT. At week 12, participants in this group, in whom, polypoidal lesions had completely regressed on ICGA would enter into the treat and extend (TNE)phase. Participants with presence of polypoidal lesions (PL) on ICGA (with or without fluid on OCT) would continue three 4-weekly injections till week 24, and enter TNE phase from week 24 onwards. 0 None 3 39 10 39 View
Fixed Group The participants received an induction phase of treatment defined as 4 weekly intravitreal aflibercept 2mg/0.05ml at week 0, week 4 and week 8. At week 12, all participants had repeat ICGA and OCT. Participants in the fixed group went on to receive fix doses of 8-weekly aflibercept 2mn/0.05ml after the induction phase for the remaining duration of the study. 0 None 0 13 4 13 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cancer NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Ulcer NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fall NON_SYSTEMATIC_ASSESSMENT Social circumstances None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Drop in Visual Acuity SYSTEMATIC_ASSESSMENT Eye disorders None View
riased intraocular pressure SYSTEMATIC_ASSESSMENT Eye disorders None View
Raised blood pressure SYSTEMATIC_ASSESSMENT General disorders None View
Rapid Active Disease Progression SYSTEMATIC_ASSESSMENT Eye disorders None View
Stye (Extra-Ocular) SYSTEMATIC_ASSESSMENT Eye disorders None View
Punctate epithelial erosion SYSTEMATIC_ASSESSMENT Eye disorders None View
Peri-orbital Oedema (Extra-Ocular) SYSTEMATIC_ASSESSMENT Eye disorders None View
Drop in vision due to cataract SYSTEMATIC_ASSESSMENT Eye disorders None View